M-11: Pharmacovigilance Summary Reports: Global Challenges with Harmonization of Canadian, American and European Perspectives
Regulatory Affairs Candidate
Humber College Canada
The objective of this study is to identify challenges associated with periodic safety reporting by delineating the similarities and differences between regulatory requirements defined by Health Canada (HC), the U.S. Food and Drugs Administration (FDA) and the European Medicine Agency (EMA).
This study represents an independent project with the Regulatory Affairs Program at Humber College, Toronto, Canada. Regulations for each jurisdiction were referenced along with industry expert consultations and academic reports indicating challenges faced with summary reporting globalization.
Pharmacovigilance is rapidly evolving as emerging technologies, such as computer-based reporting systems, enhance safety data analysis. To adapt to these changes, regulatory agencies have been refining safety regulations. Navigating global pharmacovigilance reporting requirements is a hefty task as Health Canada (HC), the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) each enforce their own legislation. However, with the advent of globalization, regulatory requirements are becoming more aligned. While Periodic Safety Update Reports (PSUR) (developed by the International Council for Harmonization; ICH) were previously accepted by all three jurisdictions, with its evolution into the Periodic Benefit Risk Evaluation Report (PBRER) the EMA and the FDA have rapidly adopted the newer format. The EMA replaced the PSUR format with the PBRER format entirely; however, American sponsors can only submit PBRER reports under defined conditions. HC accepts summary reports prepared in the PSUR/PBRER formats.
While global harmonization of periodic safety reporting is underway , complete assimilation has yet to be achieved as report content and timelines differ across jurisdictions. While the FDA and EMA both require step-by-step reporting in the years following market authorization, the frequency of reporting differs. In Canada, regulations require the preparation of annual summary reports, but these do not need to be submitted unless requested by HC or if there is a significant change in the product’s risk-benefit profile. Canadian market authorization holders must also be prepared to compile and submit issue-related summary reports ad-hoc. Jurisdiction-specific reporting requirements differ on the bases of case source (i.e. domestic/international; solicited/unsolicited), seriousness and expectedness. Thus, while the same summary report formats are accepted by HC, FDA and EMA, the content itself differs.
While global harmonization of pharmacovigilance summary reporting has been partially achieved, jurisdiction-specific laws and regulations complicate the process. Market Authorization Holders (MAHs) must be vigilant and aware of new pharmacovigilance changes provided by distinct regulatory authorities. As reporting timelines and accepted content differ across jurisdictions, global MAHs must tailor their regulatory reporting strategy to encompass all applicable data in the preferred formats. MAHs may choose to employ centralized safety writing teams that liaise with colleagues in each jurisdiction, thereby ensuring that reporting requirements are met in a timely manner. In summary, the changing regulatory landscape, brought on by new technologies and globalization, provides an efficient platform for MAHs to purposefully adapt and modernize summary reporting strategies in line with the evolving field of pharmacovigilance.
Eliane Barras, M.Sc., B.Sc. (Hon.) (1)
Marissa Fernandez, MD, BS Pharm, ASQ CQA (1) (2)
Mojgan Rezvani, Ph.D., M.Sc., M.Sc. (Edu), B.Sc. (Spec. Hon.), OCT (1)
(1) Humber College, 205 Humber College Blvd., Toronto, Ontario, Canada M9W 5L7
(2) Patient Safety Department, Baxter Canada, 7125 Mississauga Rd., Mississauga, Ontario, Canada, L5N 0C2